Two Dose Epidural Morphine for Post-cesarean Analgesia

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-06-30

Brief Summary

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The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Detailed Description

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This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Conditions

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Pain Morphine Adverse Reaction

Keywords

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Post-cesarean analgesia Second dose of epidural morphine after surgery Post-operative analgesia Self-administered epidural morphine Pain management after cesarean

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epidural Morphine

Group receiving 3mg epidural morphine, 24 hours after the initial dose

Group Type ACTIVE_COMPARATOR

Epidural Morphine

Intervention Type DRUG

Patients will be given 3mg epidural morphine, 24 hours after the initial dose.

Epidural Saline

Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.

Group Type PLACEBO_COMPARATOR

Epidural Saline

Intervention Type DRUG

Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.

Interventions

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Epidural Morphine

Patients will be given 3mg epidural morphine, 24 hours after the initial dose.

Intervention Type DRUG

Epidural Saline

Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.

Intervention Type DRUG

Other Intervention Names

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DepoDur Sodium Chloride Solution

Eligibility Criteria

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Inclusion Criteria

* Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria

* Emergent cesarean section
* Coagulopathy
* Failed epidural anesthesia or patchy block
* General anesthesia
* Use of epidural chloroprocaine
* Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
* Severe opioid side effects
* History of chronic opioid use
* History of chronic pain
* History of obstructive sleep apnea
* Morbid obesity (Body Mass Index (BMI)\>45 kg/m2)
* Height under 4' 10" (147 cm)
* Documented dural puncture by the epidural (Tuohy) needle
* Preeclampsia
* Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Allison Lee

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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New York Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.

Reference Type BACKGROUND

PMID: 8213024 (View on PubMed)

Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.

Reference Type BACKGROUND

PMID: 10735794 (View on PubMed)

Other Identifiers

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AAAL3857

Identifier Type: -

Identifier Source: org_study_id

Two Dose Epidural Morphine for Post-cesarean Analgesia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Epidural Morphine

Epidural Morphine

Epidural Saline

Epidural Saline

Interventions

Epidural Morphine

Epidural Saline

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Columbia University

Responsible Party

Allison Lee

Principal Investigators

Allison Lee, MD

Locations

New York Presbyterian Hospital

Countries

References

Zakowski MI, Ramanathan S, Turndorf H. A two-dose epidural morphine regimen in cesarean section patients: pharmacokinetic profile. Acta Anaesthesiol Scand. 1993 Aug;37(6):584-9. doi: 10.1111/j.1399-6576.1993.tb03769.x.

Palmer CM, Nogami WM, Van Maren G, Alves DM. Postcesarean epidural morphine: a dose-response study. Anesth Analg. 2000 Apr;90(4):887-91. doi: 10.1097/00000539-200004000-00021.

Other Identifiers

AAAL3857